Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

Launched by YONSEI UNIVERSITY · Jan 9, 2018

Keywords

ClinConnect Summary

This clinical trial, titled "Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients," is studying how often patients develop a type of heart rhythm problem called atrial fibrillation (AF), flutter, or tachycardia after getting a pacemaker. The research will involve patients who have had a pacemaker put in and are experiencing these heart rhythm issues. Over a period of five years, the study will compare the recurrence rates of these heart problems in two different groups of patients to understand the long-term effects of pacemakers.

To be eligible for this trial, participants need to be between the ages of 18 and 80 and must have developed AF, flutter, or tachycardia after their pacemaker implantation. They should also be able to safely receive a pacemaker according to specific guidelines. Participants will need to sign a consent form and commit to follow-up appointments after the surgery. It’s important to note that individuals with certain health conditions, like severe liver or kidney issues, or those who are pregnant, won't be able to participate. If you or a loved one is considering joining this study, you can expect regular check-ups and monitoring over the next five years to help improve our understanding of pacemakers and heart rhythm problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
• • Age: 18-80 years
• • Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
• • Estimated percentage of atrial pacing \>40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
• • Estimated percentage of ventricular pacing \>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
• • Patients who are willing to sign the informed consent.
• • Patients who are willing to receive the implantation and post-operative follow-up.
• Exclusion Criteria:
• • Persistent or permanent AF
• • Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
• • Thyroid gland dysfunction
• • Pregnancy
• • Malignant tumor
• • Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
• • Life expectancy \< 12 months
• • Patients unable or unwilling to cooperate in the study procedures.